DETAILED ACTION
Notices to Applicant
This communication is a non-final rejection. Claims 1-20, as filed 03/27/2025, are currently pending and have been considered below.
Priority is generally acknowledged as shown on the filing receipt with the earliest priority date being 11/21/2019.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon and the rationale supporting the rejection would be the same under either status.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Long!, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. 12,283,360 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application is generally broader than the reference patent.
Instant claim
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-7, 9, 14-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow (US20110238082A1) in view of Agnello (US20180374568A1).
Regarding claim 1, Wenderow discloses: A system for use in performing a contrast enhanced medical imaging procedure (“provide a standardized visual display of information related to each of robotic catheter system 17, contrast media delivery device 20, and/or inflation device 22,” [0083]; FIG. 1), the system comprising:
--a medical imaging device disposed in a medical imaging device bay (imaging system 60 is in lab unit 12 in FIG. 1);
--a contrast injector disposed in the medical imaging device bay (“Robotic catheter system 17, contrast media delivery device 20, and inflation device 22, are each positioned near patient 18 on separate support structures 24, 26, and 32 attached to patient bed 28,” [0066]);
--a camera positioned to have a field of view including at least the contrast injector (“Lab unit 12 may include a video camera so that the user at workstation 14 is able to see patient 18 within lab unit 12 when workstation 14 is located such that direct visual inspection of lab unit 12 is not possible,” [0031]; FIG. 1; “While not shown, contrast media delivery device 20 may be used with the catheter procedure system shown in FIGS. 1-4,” [0068]); and
--at least one processor operatively connected with the camera (“Controller 340 includes a processing circuit 342, memory 344, communication module or subsystem 346, communication interface 348,” [0041]; “Further, as shown in FIG. 10, communication hub 90 may also be configured to facilitate communication between controllers 62, 64, and 66 and the imaging system 60, patient sensors 68, hospital network 70, and hospital inventory system 74 via communication links 38. In another embodiment, the monitors, controls, and additional output devices associated with each controller may communicate through communication hub 90 via communication links 38,” [0089]) and configured to:
--share a video or a screen of at least one of the medical imaging device or the contrast injector at a remote display, wherein the video or the screen presents injector settings of the contrast injector (“workstation 14 is a remote workstation located, for example, in either a procedure room or a separate control room. In one embodiment, a transparent protective screen or shield (e.g., leaded glass, etc.) may be positioned between workstation 14 and lab unit 12 to shield the user at workstation 14 from radiation generated within lab unit 12 (e.g., by imagining system 60). Workstation 14 may be located at any place within a hospital. Workstation 14 may also be located at any location outside of the hospital, such as in a physician's offsite office, mobile workstation trailer, etc,” [0031]; “Contrast media display 54 is configured to provide various information to the user regarding the delivery of contrast media to patient 18. For example, contrast media display 54 may display the amount of contrast media delivered during the current procedure, the type of contrast media being delivered, the current rate of delivery, the amount of contrast media left in the reservoir of contrast media delivery device 20, etc,” [0074]),
--output an alert if the (“, user assistance module 358 may be configured to alert (e.g., through display of an icon, audible alarm, etc.) a user that the inflatable device has been expanded to the predetermined value (e.g., size, pressure, etc.). In another embodiment, user assistance module 358 may be configured to alert (e.g., through display of an icon, audible alarm, etc.) a user that the amount of fluid (e.g., contrast media, medicine, etc.) delivered via control of a fluid delivery device, such as contrast media delivery device 20, has reached a predetermined value (e.g., volume, rate, etc.),” [0050]).
Wenderow does not expressly disclose but Agnello teaches:
--extract image frames from the shared video or the shared screen (“receiving a video stream from the medical device, capturing an image from the video stream, transmitting the image to the server via a data network, and extracting the data from the image,” abstract; claim 1),
--screen-scrape the injector settings of the contrast injector from the image frames (“extracting the first and second medical data from the first and second images includes optical character recognition (OCR) of the first and second images,” [0008]; “implement a system to capture information from the graphical display in order to extract information from the waveforms and plots displayed and deliver the information to medical professionals remotely,” [0004]; “Operational and/or medical data unit 632 may be an application that databases and organizes the data extracted from OCR unit 630 and/or DSP unit 634. For example, operational data unit 632 identifies the type of data extracted by OCR unit 630 and/or DSP unit 634, and categorize the data into operational and/or medical conditions. Operational and/or medical conditions may include pressure, flow rate, pump speed, temperature, voltage, current, and biometric conditions,” [0071]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand Wenderow’s remote catheter procedure system to include Agnello’s frame capture and OCR techniques to capture operational settings because this would allow medical professionals to view displayed data while they are remote from the patient (Agnello [0003]-[0004]).
Additionally, it can be seen that each element is taught by either Wenderow or Agnello. The OCR capture of displayed data in Agnello does not affect the normal functioning of the elements of the claim which are taught by Wenderow. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Agnello with the teachings of Wenderow since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Regarding claim 6, Wenderow further discloses: wherein the camera is disposed in a medical imaging device bay (“Lab unit 12 may include a video camera so that the user at workstation 14 is able to see patient 18 within lab unit 12 when workstation 14 is located such that direct visual inspection of lab unit 12 is not possible,” [0031]).
Regarding claim 7, Wenderow further discloses: wherein the video or the screen is of a control user interface for the medical imaging device and the injector settings of the contrast injector (“Integrated monitor 204 is configured to display all information for a particular procedure, including information related to robotic catheter system 17, to contrast media delivery device 20, and/or to inflation device 22, on a single display device,” [0092]).
Regarding claims 9 and 16, the claims are substantially similar to claim 1 and are rejected with the same reasoning. The Examiner further notes that Wenderow discloses in [0042]: Memory units described herein, such as memory unit 344 (e.g., memory device, storage device, etc.), may be one or more devices for storing data and/or computer code for completing and/or facilitating the various processes described in the present disclosure.
Regarding claims 14 and 15, the claims are substantially similar to claims 6 and 7 and are rejected with the same reasoning.
Regarding claim 20, the claim is substantially similar to claim 7 and is rejected with the same reasoning.
Claims 2, 3, 5, 10-11, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow (US20110238082A1) in view of Agnello (US20180374568A1) and Adams (US20150367065A1).
Regarding claim 2, Wenderow discloses: the at least one processor is further configured to retrieve a weight of a patient undergoing the contrast enhanced medical imaging procedure from a patient database (“first monitor 304 and a second monitor 306 may be configured to display image data (e.g., x-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), patient record information (e.g., medical history, age, weight, etc.),” [0034]) and alerts ([0050]).
Wenderow does not expressly disclose but Adams teaches: the alert criterion is based on the weight of the patient (“a patient weight is entered at 508 c. Subsequently, that data is transmitted by the pump device to aggregating server 102,” [0074]; “A hard limit is often defined as a limit for which a selected infusion parameter that is outside of the limit results in generation of an alert and rendering of the pump inoperative or unable to accept selection or input of the parameter,” [0008]; FIG. 10).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the catheter quality assurance system of Wenderow and Agnello to include the patient drug alerts of Adams because it would improve the safety of the infusion (Adams [0007]).
Regarding claim 3, Wenderow does not expressly disclose but Adams teaches: the processor is further configured to retrieve an age of a patient undergoing the contrast enhanced medical imaging procedure from a patient database; and the alert criterion is based on the age of the patient (age-based alerts in [0075]-[0077]).
The motivation to combine is the same as in claim 2.
Regarding claim 5, Wenderow does not expressly disclose but Adams teaches: the screen scraped injector settings include a screen scraped contrast dose amount; the at least one processor is further configured to retrieve a maximum contrast dose amount value; and the alert criterion is based on comparison of the screen scraped contrast dose amount and the maximum dose amount (“compare a particular infusion to the new upper and lower soft limits. Therefore, in a feature and advantage of various embodiments, user-interactive limiting values are implemented on a drug library for a syringe pump. For example, a slidable Lower Soft Limit (LSL), Upper Soft Limit (USL), Lower Hard Limit (LHL), and/or Upper Hard Limit (UHL) can be utilized to group and ungroup data in the drug library data sets to present limits in relation to known prior infusions,” [0012]; ).
The motivation to combine is the same as in claim 2.
Claims 10, 11, 13, and 17 are substantially similar to claims 3-4 and are rejected with the same reasoning.
Claims 4, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow (US20110238082A1) in view of Agnello (US20180374568A1) and Bae (Bae, K.T. (2010) Intravenous Contrast Medium Administration and Scan Timing at CT: Considerations and Approaches. Radiology, 256, 32-61.).
Regarding claim 4, Wenderow further discloses: the screen scraped injector settings include a screen scraped timed injection delay (“Contrast media controls 52 may be configured to allow the user to control various aspects of contrast media delivery (e.g., speed or rate of delivery, amount of contrast media delivered, timing of delivery, etc.),” [0074]).
Wenderow does not expressly disclose but Bae teaches: the at least one processor is further configured to retrieve temporal information related to the contrast enhanced medical imaging procedure based on the screen-scraped injection settings; and the alert criterion includes a criterion based on comparison of the screen-scraped timed injection delay and a range of temporal delay values in the retrieved temporal information (“The scan delay is determined as the sum of contrast material arrival time plus an additional (diagnostic) delay,” page 48).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the catheter quality assurance system of Wenderow and Agnello to include the scan delay of Bae because it would “maximize contrast enhancement during the scanning” (page 43) and “improve patient care” (page 33).
Claims 12 and 18 are substantially similar to claim 4 and is rejected with the same reasoning.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wenderow (US20110238082A1) in view of Agnello (US20180374568A1) and Webb (US20010037366A1).
Regarding claim 8, Wenderow further discloses: a natural language communication link between the medical imaging device bay and a remote location of the remote display, wherein the natural language communication link is configured for a remote operator at the remote location to provide remote assistance to a local operator at the medical imaging device bay (“Yet other devices 15 for transferring voice and/or other audible information may be coupled to communications network 6. This may include a telephone or some other type of speaker system,” [0044]; FIG. 10; “This signal data includes the position of a pointer that may be manipulated at multiple locations so that communication is facilitated between the various experts discussing and viewing the data, and further includes video data obtained from the patient site,” [0016]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the catheter quality assurance system of Wenderow and Agnello to include the communication techniques of Webb because this would facilitate collaboration among experts during an imaging exam and thus improve patient outcomes (see Webb [0016]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wenderow (US20110238082A1) in view of Agnello (US20180374568A1) and Reiner (US20090094058A1).
Regarding claim 19, Wenderow does not expressly disclose but Reiner teaches: storing the screen-scraped injector settings annotated by an identification of the contrast enhanced medical imaging procedure in a database (“The contrast injection device 5 stamps the data from the contrast injection device 5, and records the type and volume of contrast administered, injection rate and pressures, and contrast extravastion. These data can be stored in the database 113 by the program 110 and directly correlated with the imaging modality (e.g., CT, MRI) to provide a direct linkage between contrast delivery and the derived imaging data,” [0091]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the catheter quality assurance system of Wenderow and Agnello to include the storage of injector settings as taught by Reiner because it would enable users to evaluate actual, historical treatment and thus improve patient treatment over time (Reiner [0085]-[0087]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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/JOSHUA B BLANCHETTE/Primary Examiner, Art Unit 3624
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